Process Optimization Using Design of Experiments

The challenge:Can you validate my cGMP process and get my product to market faster at a lower cost?

How we said yes:Albemarle has extensive expertise in the Design of Experiments (DoE) approach - the modern alternative to single-variable experimentation. In our research facilities, DoE is used to conduct process optimization in a rapid, responsive fashion, while supporting efforts for cGMP process validation. (The DoE approach can also be applied to non-GMP process development.) In our experience, DoE is an excellent course for facilitating reduced costs and time to market.

Current Trends in ICH GuidelinesAlbemarle's DoE methods fully support the FDA ICH Quality by Design (QbD) initiative. FDA publications that have had an impact on our work:

Albemarle is a leading specialty chemical company providing innovative chemistry solutions to customers in over 100 countries around the world. We are committed to creating value for our shareholders, customers and employees, while continually striving for excellence by doing the right things the right way.